International Surgery Journal

Kumar B et al. Int Surg J. 2016 Nov;3(4):2087-2091

http://www.ijsurgery.com pISSN 2349-3305 | eISSN 2349-2902

DOI: http://dx.doi.org/10.18203/2349-2902.isj20163579
Original Research Article

Prospective study to correlate the level of glycosylated haemoglobin

with wound healing, vasculopathy and neuropathy
in diabetic foot patients
Brajkishor Kumar, Manish Kumar Mishra*, Ajit Sinha, Rajesh Kumar Soni,
Dharmendra Kumar Patel

Department of Surgery, VMMC and Safdarjung Hospital, New Delhi, India

Received: 11 July 2016

Accepted: 10 August 2016

*Correspondence:
Dr. Manish Kumar Mishra,
E-mail: drmanishmishravmmc@gmail.com

Copyright: the author(s), publisher and licensee Medip Academy. This is an open-access article distributed under
the terms of the Creative Commons Attribution Non-Commercial License, which permits unrestricted non-commercial
use, distribution, and reproduction in any medium, provided the original work is properly cited.

ABSTRACT

Background: Diabetes mellitus is a prevalent global health problem and diabetic foot represents one of its dreadful
complications. Early aggressive approach and multidisciplinary intervention prevent limb loss and disease fatality.
Glycosylated haemoglobin (HbA1c) reflects long term glycaemic control and helps in prediction of complications as
well as response to treatment.
Methods: A total of 50 patients with diabetic foot ulcer (Wegner grade 1, 2) made nucleus of this study. Every
patient underwent proper clinical, hematological and sonological assessment. Optimum treatment was provided and
the effect of improvement in HbA1c value was correlated with duration of wound healing, vasculopathy and
neuropathy over a 12 week follow uu.
Results: Mean age of presentation was 53.4 years and patients developed diabetic ulcers (Wegner grade 1, 2) at a
mean HbA1c value of 6.6. Foot trauma was inciting event in 70% cases. 70% patients had neuropathy and 30% had
vasculopathy at presentation. Mean duration of healing was 42.6 days. Healing was faster in the group with lower
HbA1c; however there was no improvement in neuropathy or, vasculopathy in 12 weeks duration.
Conclusions: Based on the observations of present study it may be submitted that lower HbA1c value contributes to
faster wound healing, however it doesnt improve neuropathy and/or vasculopathy over duration of 12 weeks.

Keywords: Diabetic foot, Foot ulcers, Glycosylated haemoglobin, Neuropathy, Vasculopathy, Wound healing,
Wegner grade

INTRODUCTION diabetes, have been implicated as the primary underlying

Diabetes mellitus is one of the commonest global non-
communicable health-care problem, carrying a predicted
pandemic score of 366 million population by 2030.1
According to the ICMR-INDIAB study, there are 62.4
million people living with diabetes in India alone, making
it diabetic capital of the world.2 About 15% of all such
patients develop a foot ulcer in their lifetime.3
Neuropathy and ischemia, two common complications of
risk-factors in the development of foot-ulcers while
hyperglycemia contributes to delayed and impaired
wound healing.4
Treatment of diabetic foot syndrome involves
multidisciplinary approach in achieving euglycemia and
needs serial debridement/ disarticulation/ amputation as
per the grade of ulcer/ foot gangrene, else it could be life-
threatening to the patient.

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 Kumar B et al. Int Surg J. 2016 Nov;3(4):2087-2091
Glycosylated haemoglobin (HbA1c) is a measure of
beta-N-1-deoxy fructosyl component of haemoglobin,
which is formed by non-enzymatic glycation pathway,
due to hemoglobins exposure to plasma glucose,
depicting the average blood glucose level over previous
2-3 months span.5 American Diabetic Association has
included HbA1c in the diagnosis of diabetes mellitus,
with a cut-off value of 6.5.6 Although it is clear from
literature review that strict glycaemic control prevents
complications, the relationship amongst HbA1c value,
wound healing, vasculopathy and neuropathy in diabetic
foot patients is less well defined.
The objective of this study was to co-relate the influence
of level of glycosylated haemoglobin on wound healing,
vasculopathy and neuropathy in diabetic foot patients.
METHODS
The proposed study was conducted in the department of
surgery, Vardhman Mahavir medical college and
Safdarjung hospital, New Delhi, in collaboration with the
department of biochemistry, department of radio
diagnosis and department of microbiology over a period
of 18 months.
Patients presenting to surgical emergency, surgical
outpatient department and diabetic foot clinic with lower
limb ulcers were selected on the basis of clinical history,
physical examination, blood investigation and duplex
ultrasound. Proper treatment was provided and they were
re-assessed at 12 weeks.
Inclusion criterion
Diabetic foot ulcers grade 1 & 2 (Wagner
Classification).
Exclusion criteria
Pregnant ladies
Age >80 years
Patients with S. creatinine > 2 mg/dl
Diabetic foot ulcers grade 3, 4 and 5 (Wagner
classification).
Study protocol submitted for approval to local ethical
committee. All patients were informed about the
intervention and written informed consent taken.
Data was collected at presentation and at 12 weeks of
holistic treatment using proper history, thorough
examination of patient, limb and ulcer, HbA1c
assessment as well as duplex arterial sonography of lower
limb.
Patient work-up (At presentation and at 12 weeks
following treatment)
History
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Duration and family history of diabetes, compliance to
treatment, history of numbness, decreased sweating,
corns/callosities and ulcer/abscess of lower limb.
Clinical examination
Clinical nutritional assessment, palpation of all peripheral
pulses, signs of chronic limb ischemia, ulcer evaluation
and neurological examination using pinprick sensation,
touch sensation by Semmes Weinstein filament, vibration
sensation by 128 Hz tuning fork and ankle reflex.
Haematological investigations
Haemogram, fasting and post-prandial blood sugar level,
renal function test and HbA1c assessment.
Radiological investigations
Vasculopathy assessment by ankle brachial pressure
index (ABPI) using hand held Doppler and duplex
arterial sonography of both lower limbs.
Treatment approach
Under strict glycemic control, patients were followed up
at regular intervals and ulcers were debrided surgically.
Appropriate antibiotic(s) was advised as per the tissue
culture-sensitivity report, and moist dressings applied. At
12th week of treatment, patients were re-assessed by
history (for improvement in symptoms), clinical
examination (for ulcer healing, peripheral pulsations,
features of limb ischemia and neurological deficits),
biochemically (HbA1c value) and sonologically (ABPI as
well as Duplex arterial flow pattern).
Statistical analysis
Data was fed into Microsoft excel format in computer
and was analyzed using SPSS statistical software, version
16. Categorical variables were presented as numbers and
continuous data was presented as Mean (+/- standard
deviation) or, median (min-max) as appropriate. The
comparison between qualitative data was determined by
applying chi-square or Fischer exact test. Continuous data
was compared by student T-test/ Man Whitney U-test
wherever required. P-value less than 0.05 were
considered significant.
RESULTS
Total 54 patients, complying with inclusion criteria, were
enrolled in the study and received optimal treatment from
department of surgery at Safdarjung hospital, New Delhi,
India. All had unilateral limb involvement. 4 patients lost
to follow-up. They were assessed at the time of first
presentation and at 12th week of treatment. The mean age
of presentation was 53.4 years with a male (70%)
preponderance. 60% had short history of diabetes (less
than 5 years) and there was preceding history of foot
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 Kumar B et al. Int Surg J. 2016 Nov;3(4):2087-2091

trauma in most (70%) cases. 84% had Wagners grade 1 Following 12 weeks of holistic treatment, though the
diabetic ulcer and 16% had grade 2 ulcers. Neuropathy glycemic status of population improved (mean HbA1c
(predominantly sensory) was noted in 70% patients, 6.4), yet 25 patients retained their value higher than 6.5
while 30% had vasculopathy (Figure 1, 2). Mean (Table 1).
glycosylated haemoglobin level of study population was
6.6 and 25 patients had value higher than 6.5 (mean
7.23).

Table 1: Age, sex, grade of foot ulcer, pre and post treatment HbA1c values.

Number of Number of Number of

Mean HbA1c(std.
Mean Age patients and Mean glycosylated patients at patients at
Total number dev.) of patient
(years)std. grade of foot haemoglobin +/- presentation 12 weeks
of patients group with value
dev. ulcer at std. dev. with HbA1c with HbA1c
more than 6.5
presentation value value
Less Less
than than
Wegner More More
Wegner At 0 At 12 or or At 0 At 12
Male Female Grade than than
Grade 1 week week equal equal week weeks
2 6.5 6.5
53.411.9 to to
years 6.5 6.5
35 15 42 08 06.60.7 06.40.7 25 25 25 25 07.20.5 07.10.5
N = 50 N = 50 P-value = 0.16 N = 50 N = 50 P-value = 0.48

Table 2: Mean duration of wound healing and its correlation with HbA1c value.

Mean duration (days) of

Mean duration (days) of wound healing in two groups std. dev.
wound healing +/- std. dev.
Mean duration (days) of wound healing Mean duration (days) of wound healing in
42.617 in patient group with HbA1c up to 6.5 patient group with HbA1c more than 6.5
3913.1 46.520
P-value 0.13

mean glycosylated haemoglobin value 8.65, which

remained 8.5 at 12 weeks of treatment. However no
subjective or, objective change was noted in vasculopathy
and neuropathy in follow-up (Table 2).

Sensory
15
Neuropathy
23
Motor Neuropathy

No Neuropathy 5
10
12 Post tibial art
vasculopathy
No vasculopathy

Ant tibial art

vasculopathy
35
Figure 1: Number of patients with neuropathy.

Mean duration of wound healing was 42.6 days (Wagner

grade 0). Healing was earlier in patients whose HbA1c
was less than or equal to 6.5 (39 days versus 46.5 days).
In two patients foot ulcer worsened to higher grade and
needed amputation. Both these patients had pre-treatment Figure 2: Number of patients with vasculopathy.

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 Kumar B et al. Int Surg J. 2016 Nov;3(4):2087-2091
DISCUSSION
Diabetes has become one of the largest global healthcare
problems of the century and the burden of disease is
predicted to double between 2000 and 2030.1 Diabetic
foot syndrome is a complex and heterogeneous disorder
which affects 1 out of 7 patients with diabetes at least
once in their lifetime with relevant consequences both on
lower limb and general morbidity.3 Presently there is no
absolute way to prevent the development of this
disastrous disease, however a good glycemic control has
been proven to retard the progression of complications
like neuropathy, angiopathy, foot infections etc.
HbA1c reflects glycemic control over past 2-3 months
and its role in management of diabetes is well
established.6 In ADVANCE trial, a target 6.5 HbA1c
value was found to drastically reduce the macro and
microvascular complications.7
Prevalence of diabetic foot complications increases with
age and duration of disease. In contrast to the West,
where mean age of presentation is 61 years, here the
presenting population is younger, which is in accordance
with the demographic data obtained during a study
conducted in North India over 678 diabetic patients in
which mean age with foot ulcer was 55.3 years with male
preponderance (71.1%).8,9 Usually patients with 8 or
more HbA1c have foot ulcers, however they were present
at a mean value of 6.6 in our study.8,10 In present study,
the average duration of diabetes mellitus was 4.5 years,
which was of relatively shorter duration. Shailesh et al in
their study over prevalence of diabetic foot ulcer and
associated risk factors in North India, found mean
duration of diabetes to develop foot ulcers 11.5 years.9
70% of our patients had preceding history of foot trauma.
Staphylococcus aureus was the commonest microbe (in
50% patients) isolated from tissue culture specimen.
Neuropathy was noticed in 70% cases. Estimate of
diabetic peripheral neuropathy varies from 9.6-78% in
different populations.13 Our 30% patients had features of
vasculopathy. Similar prevalence of vasculopathy has
been reported in other studies over diabetic foot ulcers.9,14
There was early healing (mean duration 39 days) in the
sub-group, where glycosylated haemoglobin was up to
6.5 during treatment. Christman et al in their study at
John Hopkins Wound Center, USA found similar inverse
association between it and rate of healing. For each 1.0
unit increase in HbA1c, the wound area healing rate per
day decreased by 0.028 cm2.8 Though association
between high HbA1c and peripheral vasculopathy as well
as neuropathy is well established since long, but there
was no improvement in vasculopathy or, neuropathy with
improvement in HbA1c over 12 week span.11,12
CONCLUSION
In this study, we noticed that presentation of diabetic foot
patients in India is different from western counter-part.
Here patients are developing complications like
International Surgery Journal | October-December 2016 | Vol 3 | Issue 4
neuropathy, vasculopathy and foot-ulcers at an early age,
despite shorter duration of this disease well as at
relatively lower HbA1c value. So, shorter duration of
diabetes, even mild, is harmful. It is advisable to screen
the population for diabetes at an early age. With early
detection and prompt intervention, limb loss and other
morbidities could be minimized. Patients, as well as
family members, should be educated about importance of
strict glycemic control, foot care and early reporting of
changes to health care professionals.
ACKNOWLEDGEMENTS
Authors would like to thank Dr. Bhawna for her
assistance in analyzing the statistics of this study.
Funding: Funded by Hospital
Conflict of interest: None declared
Ethical approval: The study was approved by the
institutional ethics committee
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Cite this article as: Kumar B, Mishra MK, Sinha

A, Soni RK, Patel DK. Prospective study to
correlate the level of glycosylated haemoglobin
with wound healing, vasculopathy and neuropathy
in diabetic foot patients. Int Surg J 2016;3:2087-91.

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